CAC EXICARE Corporation

Description:

OUR NICHE

Medical Writing and Document QC

CAC EXICARE Corporation (CAC EXICARE), a 100% subsidiary of CAC Corporation, provides a one-stop clinical research service with excellent IT capability for overall pharmaceutical development life cycle from clinical trial to post-marketing. CAC EXICARE's core value includes IT enabled service from clinical development to PMS utilizing a vast experience to integrate and support industry-leading packaged software as well as home-grown packaged software such as EDC. In addition, CAC EXICARE established a shared service center for pharmacovigilance, called Pharmacovigilance Center which can offer offshore capability in collaboration with subsidiaries in India and China.

The service provision includes:

Tutorial Service: CAC EXICARE provides a tutorial service on Japanese pharmaceutical rules and regulations lectured by drug safety and pharmacovigilance experts on an ad-hoc basis.

Consulting Service and Safety Database Implementation Services: Consulting services for searching, understanding and evaluating global safety databases under the new regulatory environment in Japan is provided in response to client request. Intensive E2B consulting service covers the so-called Green Book, a guidance published by Japan Pharmaceutical Manufacturers Association (JPMA).

Computerized System Validation Service: CAC EXICARE provides a consulting service on how to handle computerized system validation (CSV) and electronic signatures/electronic records (ER/ES). Compliance training service is also provided. CAC EXICARE has extensive experiences in developing and implementing global policies and standards for CSV and ER/ES covering three major regions: the EU, the US and Japan.

Data Validation and Legacy Data Conversion Services: Starting from validation of the existing database system, legacy data conversion from a client’s old system to a new system is an area in which CAC EXICARE has strong experience over the years. CAC EXICARE carries out such activities through intensive discussions with a client and based on the client’s approval.

e-Submission Service through CAC EXICARE Gateway: Since EDI and Gateway were built for the MHLW, FDA and EMA, CAC EXICARE has focused on secure e-submission to those authorities. CAC EXICARE is a member of the e-Prompt project sponsored by the FDA and has been certified by the FDA for e-submission. In 2008, CAC EXICARE accomplished the mandatory steps for e-reporting to Eudravigilance via Gateway and allowed clients to exchange safety information with the EMEA.

Safety Data Entry, MedDRA Coding and Medical Evaluation Services: CAC EXICARE provides safety data entry, MedDRA-J coding and medical evaluation services to pharmaceutical clients, regardless of client locations. These services enable American and European pharmaceutical companies to grasp their comprehensive drug profiles and run their signal detection tools on their own databases.

Hosted Services and Risk Management Services: A pharmaceutical company can use CAC EXICARE’s hosted secure database as if it were their own and keep signal detection/risk management close at hand.

External Audit and Global SOP Preparation Services: CAC EXICARE provides an external audit service for pharmacovigilance and supports to establish a pharmacovigilance system which withstands challenges raised by FDA and EMA during inspections. CAC EXICARE supports to prepare global SOPs and maintain pharmacovigilance IT systems which meet global requirements. CAC EXICARE’s accurate knowledge on FDA and EMA’s regulations and IT skills enables clients to comply with global rules and regulations.